The PRAGMATYK clinical study

STUDY BASICS

Do you have moderate-to-severe plaque psoriasis? You may be eligible for a research study to better understand the safety of long-term use of a study drug. If you qualify and choose to participate in the study, you will receive either the study drug, as an oral tablet, or another approved treatment for moderate-to-severe plaque psoriasis as an injection under the skin.

STUDY PURPOSE

The purpose of this study is to better understand the safety of long-term use of deucravacitinib (the study drug) in adults 40 years of age or older with moderate-to-severe active plaque psoriasis who have one or more cardiovascular risk factors.

COULD THIS STUDY BE RIGHT FOR YOU?

• Are aged 40 years or older
• Have moderate-to-severe plaque psoriasis
• Are eligible for phototherapy (treatment that exposes your skin to certain types of ultraviolet light) or systemic treatment of psoriasis (treatment with drugs that work throughout the entire body)
• Have one or more certain cardiovascular risk factors

WHAT PARTICIPANTS CAN EXPECT

The study will take up to 5 years and will be split into 3 separate periods:

1. Screening (4 weeks before the study begins): During the screening visit, you will be asked to provide informed consent before the study team will ask you about your medical history and conduct health tests and procedures to determine if you qualify for the study.   – During informed consent, the study will be explained to you, and you will be able to ask any questions you may have. If you decide that you would like to take part in the study, you will sign the Informed Consent Form before any screening tests begin. 
2. Treatment period (up to 5 years): After the screening visit, you will be randomly assigned to your treatment group, and you will receive either the study drug or ustekinumab for up to 5 years. During the treatment period, you will be required to return to the clinic for assessments at Weeks 12 and 26, then every 6 months until the remainder of the study. During these visits, you will receive your study treatment, and your health will be monitored.
3. Follow-up (60 days after the last dose of study treatment): At the end of the study, you will complete a safety follow-up visit that will be conducted remotely (by phone or video call) so that you don’t have to attend the clinic in person.